ELRR by TEM Versus Laparoscopic TME in iT2N0M0 SMALL LOW RECTAL CANCER (ELRRvsLTME)
This study has been completed.
Sponsor:
University of Roma La Sapienza
Collaborator:
Università Politecnica delle Marche
Information provided by (Responsible Party):
Lezoche Emanuele, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT01609504
First received: September 15, 2011
Last updated: May 29, 2012
Last verified: May 2012
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Purpose
The present prospective randomized study investigated the results of ELRR (ENDOLUMINAL LOCO-REGIONAL RESECTION BY TRANSANAL ENDOSCOPIC MICROSURGERY) versus LTME (LAPAROSCOPIC TOTAL MESORECTAL EXCISION) in the management of 100 patients with iT2N0M0 small low rectal cancer after Neoadjuvant Treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Rectal Cancer |
Procedure: ELRR BY TEM Procedure: LTME |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Controlled Clinical Trial: Endoluminal Loco-regional Resection (ELRR) by Transanal Endoscopic Microsurgery (TEM) Versus Laparoscopic Total Mesorectal Excision (LTME) in it2n0m0 Small Low Rectal Cancer |
Resource links provided by NLM:
Further study details as provided by University of Roma La Sapienza:
Primary Outcome Measures:
- oncological result in term of local and/or systematic recurrence [ Time Frame: 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 42, 48, 54, 60 months after operation ] [ Designated as safety issue: Yes ]To evaluate local and/or systematic recurrence, all patients were followed up prospectively by clinical examination, measurement of tumour markers and sigmoidoscopy every 3 months for the first 3 years, and every 6 months thereafter. Whole-body CT and pelvic MRI were repeated every 6 months for the first 5 year. All patients had a minimum follow-up of 5 years.
Secondary Outcome Measures:
- Morbidity [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 and 6 days each group ] [ Designated as safety issue: No ]No. of patients with postoperative complications
- operative time [ Time Frame: operative time ] [ Designated as safety issue: No ]operative time (minutes)
- blood loss [ Time Frame: during time of operation ] [ Designated as safety issue: No ]blood loss (ml)
- analgesic use [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 and 6 days each group ] [ Designated as safety issue: No ]No. of patients receiving analgesia
- 30 day mortality [ Time Frame: at 30 days from operation ] [ Designated as safety issue: Yes ]No. of patients died within 30 days from operation
- hospital stay [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 and 6 days each group ] [ Designated as safety issue: No ]hospital stay (days)
- cancer-related mortality [ Time Frame: 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 42, 48, 54, 60 months after operation ] [ Designated as safety issue: Yes ]No. of patients died for cancer. To evaluate local and/or systemic recurrence, all patients were followed up prospectively. After 5 year every 12 months. All patients had a minimum follow-up of 5 years
| Enrollment: | 283 |
| Study Start Date: | April 1997 |
| Study Completion Date: | April 2004 |
| Primary Completion Date: | April 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Transanal Endoscopic Microsurgery
Patients were treated by TEM as follows: mucosal incision included all the tatoo spots performed at admission staging, in order to excise a minimum of 1 cm of normal mucosa around the tumor, according to its diameter before NT (ELRR- Endo Luminal Loco Regional Resection)
|
Procedure: ELRR BY TEM
The surgical technique of ELRR was as follows: mucosal incision included all the tatoo spots performed at admission staging, in order to excise a minimum of 1 cm of normal mucosa around the tumor, according to its diameter before NT
Other Name: FULL-THICKNESS + FAT EXCISION BY TEM
|
| Active Comparator: Total Mesorectal Excision |
Procedure: LTME
LAPAROSCOPIC TOTAL MESORECTAL EXCISION INCLUDING MESORECTAL (ACCORDING TO HEALD CRITERIA)
Other Name: LAPAROSCOPIC LOW ANTERIOR/ABDOMINO-PERINEAL RESECTION
|
Show Detailed Description Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Tumor located within 6 cm from the anal verge
- Tumor diameter not larger than 3 cm, and staged as iT2, N0, G1-2
Exclusion Criteria:
- Patients classified as American Society of Anaesthesiologists (ASA) 3 or 4
Contacts and Locations More Information
No publications provided by University of Roma La Sapienza
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Lezoche Emanuele, Professor, University of Roma La Sapienza |
| ClinicalTrials.gov Identifier: | NCT01609504 History of Changes |
| Other Study ID Numbers: | URBINO-LEZ-1995 |
| Study First Received: | September 15, 2011 |
| Last Updated: | May 29, 2012 |
| Health Authority: | Italy: National Monitoring Centre for Clinical Trials - Ministry of Health |
Keywords provided by University of Roma La Sapienza:
|
Rectal cancer Radiochemotherapy Transanal Endoscopic Microsurgery Laparoscopic Resection |
Additional relevant MeSH terms:
|
Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on May 19, 2013